Drug product
Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.
D-1155-2022
Product summary
- Event
- Event 90340
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4608 bottles
- Official record key
drug-enforcement:D-1155-2022
Official wording
Reason: Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Code information: Lot #: MHC1430A, Exp. Date 09/2023
Distribution pattern: nationwide within the United States
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specification; oversized tablet found in a bottle